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I’m of the opinion that we don’t run enough clinical trials for things that are not obviously medicines or medical devices, but that people generally assume have health benefits. Things like yogurt — and sneakers. Today, Skechers proved my point by getting in trouble with the feds.

Today the Federal Trade Commission announced that Skechers USA, the discount sneaker maker that found its way to premium pricing by selling “toning shoes” with rounded soles that were supposed to strengthen muscles better than regular sneakers, would pay $40 million to settle claims “that the company deceived consumers by making unfounded claims that Shape-ups would help people lose weight, and strengthen and tone their buttocks, legs and abdominal muscles.”

Consumers who bought the shoes should go to www.ftc.gov/skechers. Besides Shape-ups, Skechers also made deceptive claims about its Resistance Runner, Toners, and Tone-ups shoes, the FTC argues, and. Consumers who bought these “toning” shoes will likewise be eligible for refunds either directly from the FTC or through a court-approved class action lawsuit.

Central to the FTC’s allegations is the argument that Skechers used bad science and celebrity endorsements (including Kim Kardashian and Brooke Burke) to sell the shoes. Two egregious-sounding examples from the FTC news release:

Shape-ups ads with an endorsement from a chiropractor named Dr. Steven Gautreau, who recommended the product based on the results of an “independent” clinical study he conducted that tested the shoes’ benefits compared to those provided by regular fitness shoes. The FTC alleges that this study did not produce the results claimed in the ad, that Skechers failed to disclose that Dr. Gautreau is married to a Skechers marketing executive, and that Skechers paid Dr. Gautreau to conduct the study.

An ad that claims consumers who wear Resistance Runner shoes will increase “muscle activation” by up to 85 percent for posture-related muscles, 71 percent for one of the muscles in the buttocks, and 68 percent for calf muscles, compared to wearing regular running shoes. The FTC alleges that in citing the study that claimed to back this up, Skechers cherry-picked results and failed to substantiate its ad claims.

The idea that one type of shoes could be better than another is a testable claim — and there’s no reason that a company that wants to launch a marketing blitz on how their product will help you get in shape couldn’t spend a few million dollars on a reasonably sized study to prove that those benefits are actually there. Certainly, they could do better than relying on the husband of a marketing executive or using a weak, probably meaningless data point like “muscle activation.”

I’d like to see more studies like this one, being conducted by Nike, that randomly assigns runners to get one of three shoes: a traditional running shoe, a Nike minimalist shoe with less support, and a Vibram Five Fingers — those funny shoes that fit toes like gloves. (Full disclosure: I’ve been running in Vibrams lately, and like them, but I have no idea if I’m just falling for the latest fad.) There have been great arguments made that overly cushioned running shoes can increase the risk of certain injuries, based on studies of human biomechanics. A randomized trial can actually tell you whether that’s true.

Of course, having to actually prove marketing claims with science can be a rude awakening to companies who aren’t used to doing so. One example: Lifeway Foods, which, as I wrote in a magazine feature two years ago, complained when a clinical trial of its yogurt-like drink did not show the expected benefits. Or, to pick a bigger target, General Mills who was recently marketing Cheerios as if they were a cholesterol-lowering drug made by Merck or Pfizer. (Actually, the Cheerios ads were better than the drug company ones.) Coca-Cola‘s Vitaminwater brand is built entirely on putting vague-sounding benefits around sugar water that contains vitamins with little proof the vitamins are actually good for you. (There’s actually little evidence vitamin supplements help most people.)

One thing that’s pretty clear is that we need a better way of regulating these kinds of studies than the FTC, which applies relatively small fines after the fact. Having all these claims go through the FDA would probably be too expensive and time consuming, but we need better mechanisms to convince marketers to actually prove their claims before they push them on the broader market.

And I really am waiting for some more clinical trials of running shoes.

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Skechers were not the originals. Does this concern apply to other manufacturers as well? I see no mention of MBT who originated the design and claimed that it simulated walking in sand; a condition that would activate core muscles more than standard shoes. This claim was even made in relation to merely standing, as opposed to being an improvement over walking or running in standard fitness shoes.

I am afraid this dr. Gautraeu tried to copy the originals MBTphysiological footwear (swissmasai.com) I use the originals MBT (quite expensive!) and they are absolutely great, my visits to the pedicure finished! And a lot more to my knee and the rest problems stop) Don’t forget that the MBT are Swiss made and rules in Europe are upmost strength control to put such on the market.

Mathew – you made a passing mention of Merck in your article. They are the manufacturer/marketer of Dr. Scholl insoles, which make all sorts of claims in their advertising. It would be interesting to learn what they do to substantiate their claims. If they do a decent job of claim support with their lower cost products, why can’t the higher priced shoe companies do the same?

What a fantastic story idea! It would also be interesting to compare the level of data on their sunscreens to their medical businesses. But yes, finding out what data there are on Dr. Scholl’s would be interesting.

Come on Matt, Skechers? dr. scholl? I have an idea, how ’bout you look into the… NCAA and Monsanto? Talk about untouchable multi-billion dollar operations without any accountability… skechers? Really? Cherrios is 100% GMO CORN and nobody says a word. The NCAA is still a 501-c non-profit and nobody questions them or audits their books. Skechers? plz.

You mean in the corn starch? Cheerios are mostly oats. There are certainly legitimate criticisms about Monsanto’s business practices, and I think it would be good science to do a study in which people were randomized to eat GMO or non-GMO grains for a few years. But there is no evidence that the varieties of GM crops that are on the market are harmful to people and, in fact, there’s every reason to believe they are safe.

But there is evidence from animal studies that GMO food affects a number of systems, including organs involved in fertility, the immune system, cellular regeneration and a host of other pretty significant problems. Doing a human study for a few years is useless. You need to run longitudinal studies, ideally spanning a few generations, to see the real effect of such food. The advantage of animal studies is that they have a shorter life cycle, so genetic malformation that result from exposure to certain substances becomes evident sooner.

In fact, I have read reports that farm animals refuse to eat GMO food if they have a choice. Perhaps they are wiser than we are.

I disagree, Matthew. If the animals become infertile after a few generations, I think it is pretty alarming for the human race, especially if combined with other factors (such as exposure to electromagnetic fields from cell phone towers, microwave ovens etc.) that also affect fertility.

With the plaintiff lawyer surplus these days, maybe they will have time to chase after even the quacks who make health claims at county fairs. I recently encountered one pitching his elixir for attentiveness at a Whole Foods Market.

Anyone who wants to believe that a pair of sneakers is going to tone your legs and butt deserves to be taken. We all know that it takes thousands of lunges and squats, months of weight-resistance exercises, hours and hours of cardio and healthy eating habits to keep muscles strong and lean. Marketing is marketing and the public is the public. Long live celebrity endorsements and the sales they generate. I would hope that the readers of Forbes don’t rely on protection from the government to keep the witch doctors away.